Date: August 24, 2016
The following new items were added to the CDRH web pages on August 23, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
- Patient Preference Information - Voluntary Submission, Review in PMA Applications, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, FDA Staff, and Other Stakeholders